Competitive DynamicsIntensifying competition in the MASH landscape raises the bar for commercial viability and forces the drug to demonstrate clear and durable clinical differentiation to capture market share.
Development And Market Access RisksBroad risks including clinical development setbacks, pricing and reimbursement challenges, capital market uncertainty, and potential disruptions to trials could impede progression toward approval and launch.
Endpoint And Trial Design RiskAbsence of paired liver biopsies at critical time points leaves uncertainty around efficacy assessment given the FDA's expectation for biopsy-based endpoints, which could complicate approval strategy.